Overview

Placement of Antibiotic Powder in Wounds During the Emergency Room

Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
All
Summary
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborators:
Brooke Army Medical Center
San Antonio Military Medical Center
United States Army Institute of Surgical Research
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Vancomycin
Criteria
Inclusion Criteria:

- Subject or Legal Authorized Representative (LAR) is willing and able to provide
written informed consent.

- Adult 18 years of age or older.

- Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.

- 24 hours or less has elapsed from the estimated time of injury to study intervention.

Exclusion Criteria:

- Time from injury > 24 hours.

- Subjects who have received acute operative care (e.g., washout in the operating room
or fixation) of the open fracture at an outside facility.

- Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable
to participate in the consent process (e.g. intoxication, poly-trauma, will be
enrolled into the observational arm where passive data collection will occur).

- High-potency antibiotic powder or solution applied to the wound prior to enrollment.
Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will
be permitted.

- Documented allergies or serious reactions to vancomycin. History of uncomplicated "red
man syndrome" will not be considered a reason for exclusion.

- Pregnant subjects. If the subject is a female of childbearing potential, and she
states that she is likely to be pregnant, a pregnancy test will be performed; if
negative, the subject will be eligible for enrollment.

- Prisoners.

- Participation in other clinical research involving investigational antimicrobial
products within 30 days of randomization.